Although some active pharmaceutical ingredients are stable in a single solid state, changes such as strain of crystals of the active pharmaceutical ingredients are caused by pressure forming for formation of formulation, and decomposition of the active pharmaceutical ingredients in a pharmaceutical composition to be obtained is promoted (Patent Literatures 1 to 7). As conventional techniques to solve such problems, a method of adding a low-melting point oil and fat substance (Patent Literature 1), a method of adjusting the density and hardness of an uncoated tablet within specific ranges (Patent Literature 2), a method of adding a hydrophilic substance such as carrageenan (Patent Literature 3), a method of using wet granules (Patent Literature 4), a method of adding a saturated higher fatty acid and/or a saturated higher alcohol (Patent Literatures 5 and 6), a method of adding a sucrose fatty acid ester (Patent Literature 7), a method of adding minute gelatin spheres and/or gelatin foams (Patent Literature 8), and a method of using a monosaccharide alcohol (Patent Literatures 9 and 10) have been known.
On the other hand, some active pharmaceutical ingredients which cause gelling under a certain condition have been known (Patent Literatures 11 to 17 and Non-Patent Literatures 1 and 2). As a formulation which contains a quinolone carboxylic acid antimicrobial agent in which a main drug is stabilized, an oral composition which contains an acidic additive (Patent Literature 18) and an injection formulation which contains an acidic additive (Patent Literatures 19 and 20) have been known.